Parkinson DiseaseNCT05938673
Effects of rTSMS Associated With Treadmill Training in Patients With Parkinson's Disease
A study testing Active stimulation- intermittent theta-burst (iTBS) stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Gait changes appear and become the main cause of disability, loss of independence, falls, fractures and reduced quality of life for patients with Parkinson Disease. Optimal gait management is complex and challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Active stimulation- intermittent theta-burst (iTBS) stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 18;
- Participants with PD at Hoehn Yahr stages between 2 and 4 (moderate disease) while on-medication (i.e., at the time when their usual dopaminergic medication is clinically effective), whose primary symptom includes gait disturbance (score equal to or greater than 1 in subitem 2.12 of the MSD-UPDRS scale). Patients will be evaluated for the presence of freezing gait (freezing) through the Freezing of Gait Score (FOG-SCORE).
- While on on-medication, be able to walk independently for 30 meters or with a unilateral assistive device.
- Mini Mental State Examination (MMSE) score greater than or equal to 23.
- Sign the informed consent form.
Who cannot join
- Patients with unstabilized psychiatric comorbidities;
- Individuals who have other neurological disorders, musculoskeletal, orthopedic, cardiovascular and respiratory disorders that may affect the ability to walk on the treadmill will be excluded.
- Individuals with labyrinthine problems, using medication that may interfere with balance and performance in tests and treadmill training will be excluded.
- Individuals who have undergone deep brain stimulation surgery or epidural spinal cord stimulation will be excluded.
- Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg uncontrolled diabetes, high blood pressure, symptomatic lung or heart disease);
- Concomitant treatment with other experimental drugs;
Show all 11Show fewer
- Pregnant or breastfeeding women.
- Presence of chronic low back and lower limb pain.
- Patients who cannot walk without assistance (cane, crutch, walker) or help from another person.
- Patients with metal implants and a cardiac pacemaker.
- Patient with a history of neurosurgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403000
About this study
Official title: Effects of Repetitive Trans Spinal Magnetic Stimulation Associated With Treadmill Gait Training on Gait Disorders in Patients With Parkinson's Disease
Gait changes appear and become the main cause of disability, loss of independence, falls, fractures and reduced quality of life for patients with Parkinson Disease. Optimal gait management is complex and challenging. Some characteristics, such as gait variability, postural instability, and postural changes, continue to worsen over time despite optimal dopaminergic treatment, suggesting that additional interventions are needed. Given the physiology of gait and postural control in humans, spinal cord stimulation is a potential target for neuromodulatory approaches to gait and postural disorders. Repetitive transspinal magnetic stimulation ( rTSMS) has attracted a lot of attention, due to the possibility of modulating motor and sensory networks in a non-invasive way, activating directly the dorsal ascending pathways and projecting to the thalamic nuclei, cerebral cortex, and brainstem nuclei, thus stimulating descending motor tracts and interrupting aberrant oscillatory activity in corticobasal nuclei circuits.
The combination of non-invasive neuromodulation with other therapies can enhance the effectiveness of rehabilitation, increasing plasticity and clinical efficacy, offering a greater and more sustained effect than either therapy alone.It's recommended that patients with PD perform a specific exercise for walking, such as treadmill training (tt), that imposes an external rhythm and concentration of attention on gait, acting as an external cue or marker, promoting a more stable gait, reducing gait variability and decreasing risk of falls.
Read more
It is proposed, in this study, to develop a new treatment model through the integration of two promising and complementary approaches to improve gait disorders in PD: rTSMS and tt.
Thus, the investigators idealized the realization of the first randomized, double-blind, placebo-controlled, parallel, phase III clinical trial that will evaluate the efficacy of tt associated with rTSMS in patients with PD.
Read the detailed description
The primary objective is to evaluate the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on the change in rapid gait speed in Parkinson Disease patients. The investigators hypothesize that the association of repetitive transspinal magnetic stimulation with treadmill gait training should be superior to treadmill gait training alone in improving gait symptoms in patients with PD. Additionally, will be investigated the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on comfortable gait speed; in clinical and neurophysiological measures; in motor symptoms; in activities of daily living; in the ability to walk (total distance covered); in balance performance; in time to complete the turn; in the severity of the freezing of the gait; in mobility; in the level of physical activity; in the number and fear of falls and in the perception of quality of life of patients with PD. In addition, the possible side effects of the intervention will be evaluated.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Active stimulation- intermittent theta-burst (iTBS) stimulation, Sham stimulation
- Keywords
- Non-invasive brain stimulation, Parkinson's disease, Spinal cord stimulation, gait
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stimulation- intermittent theta-burst (iTBS) stimulationOther
During active stimulation, patients will receive intermittent theta-burst (iTBS) stimulation in T2-T3 toracic region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.Each participant will receive a total of 1,200 rTsMS pulses at 120% of resting motor threshold, determined by abdominal muscle contractions. In 3 minutes and 58 seconds, 20 trains with 20 bursts and each burst with 3 pulses at 50 Hz repeated at 5Hz with an intertrain interval of 8 seconds will be applied.Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
Sham stimulationOther
During sham stimulation, a circular magnetic coil will be positioned in the T2-T3 toracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. To create a sensation of muscle contraction and impression of active stimulation, the group will be submitted to the sensory effect of transcutaneous electrical neurostimulation (TENS) for 5 minutes, with surface electrodes placed in parallel at the T2-T3, with the parameters (80Hz,150ms, 60 mA).Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity.
| Study group | Role | What they receive |
|---|---|---|
| Sham repetitive transpinal magnetic stimulation | Sham comparator | In the Sham group a coil will be positioned in the T2-T3 thoracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. Receives: Other: Sham stimulation |
| Active repetitive transpinal magnetic stimulation | Active comparator | In the Active group, the patient will receive intermittent theta burst stimulation (iTBS) in the T2-T3 region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator. Receives: Other: Active stimulation- intermittent theta-burst (iTBS) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test- Fast walking speed
Comparison of the change in fast gait speed between active stimulation and sham stimulation during Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). Longer time to complete the test results in slower gait speed and worse performance
Measured: 4 months
Secondary outcomes (16)
10 meter walk test- Confortable walking speed
Comparison of the change in confortable gait speed between active stimulation and sham stimulation during Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). Longer time to complete the test results in slower gait speed and worse performance
Measured: 4 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part II and III
Comparison of change in Unified Parkinson's Disease Rating Scale score part II and III between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention).MDS-PDRS part II is scored from 0 to 52 with higher scores associated with worse motor related daily activities performance. MDS-UPDRS part III is scored from 0 to 132 with higher scores associated with worse motor performance in parkinson related tests.
Measured: 4 months
Freezing of Gait Score- (FOG- SCORE)
Comparison of the change in the severity of gait freezing between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). The Severity of gait freezing will be evaluated through the Freezing of Gait Score.The score was the sum of the 12 items and it ranges from 0 to 36 points. the higher the score, the worse the performance and severity of gait freezing.
Measured: 4 months
2 Minute Walk Test
Comparison of the change in the Walking capacity (total distance covered) and speed,evaluated through the 2 Minute Walk Test, between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). A shorter distance covered during 2 minutes results in a slower speed to complete the test and worse performance.
Measured: 4 months
Timed up and Go (TUG)
Comparison of the change in the functional mobility between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention), that will be evaluated through the Timed up and Go test. The time average of two measurements will be calculated. A longer average time to complete the test results in worse performance
Measured: 4 months
Timed up and Go Dual Task (TUG-DT)
Comparison of the change in the Dual-task performance between active stimulation and sham stimulation Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention), that will be evaluated through the Timed up and Go Dual Task test. The time average of two measurements will be calculated. A longer average time to complete the test results in worse performance
Measured: 4 months
Timed 360° turn test
Comparison of the change in the time to complete the turn between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention), that will be evaluated through the Timed 360° turn test. Will be taken 3 measurements for each side and the average of time and of the number of steps required to complete the turn will be calculated. A longer time and a greater number of steps to complete the turn suggests a greater commitment and worse performance
Measured: 4 months
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Comparison of change in the Balance performance between active stimulation and sham stimulation in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention), that will be measured through the Mini-Balance Evaluation Systems Test that includes 14 items scored from 0 to 2, with a maximum score of 28 and a minimum of 0, with a higher score indicating better balance performance.
Measured: 4 months
Freezing of Gait Questionnaire (FOG-Q)
Comparison of change in the subjective perception of the severity and impact of freezing on gait performance between active stimulation and sham stimulation in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention), that will be measured through the Freezing of Gait Questionnaire, that is rated on a 5-point scale (0 to 4), with a total score ranging from 0 to 24. A higher score implies that the individual's gait performance is more affected by freezing
Measured: 4 months
Falls and near falls
The occurrence of falls and near-falls will be investigated through self-report and will be compared between groups in Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). The classification of fallers and non-fallers will be obtained.
Measured: 4 months
Human Activity profile (HAP)
Comparison of change in the Level of physical activity between active stimulation and sham stimulation in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention), that will be measured through the Human Activity profile. Tare arranged in ascending order of energy cost.Based on each response, the primary scores are calculated: the maximum activity score (EMA) and the adjusted activity score (EAA).The EAA will be used in this study. The classification of physical activity level will be established through pre-defined cutoff points, with individuals classified as inactive (less than 53), moderately active (between 53 and 74) or active (greater than 74). An increase in the score indicates an improvement in the level of physical activity
Measured: 4 months
Falls Efficacy Scale- International (FES-I)
Comparison of change in the Fear of falls between active stimulation and sham stimulation in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention), that will be measured through the Falls Efficacy Scale- International, that presents questions about the concern with the possibility of falling when performing 16 activities. The total score is calculated by adding the values obtained in each item and can vary from 16 to 64 points, in which the lowest value corresponds to the absence of concern and the highest value to extreme concern regarding falls while carrying out the activities in the questionnaire. Thus, the higher the final score obtained, the lower the self-efficacy related to falls.
Measured: 4 months
Parkinson's Disease Questionnaire -39 (PDQ-39)
The perception of quality of life will be measured in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention) through the Parkinson's Disease Questionnaire -39 which is scored is from 0 to 100, higher values are associated with worse quality of life.
Measured: 4 months
Non-Motor Symptoms Scale (NMSS)
Comparison of change in the Non-Motor Symptoms between active stimulation and sham stimulation in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention) , that will be measured through the Non-Motor Symptoms Scale. The NMSS consists of 30 items and each item's score is based on severity (from 0 to 3) and frequency scores (from 1 to 4).The range for the NMSS total scores is 0-360. Higher scores indicate greater severity of non-motor symptoms
Measured: 4 months
The Parkinson Disease Pain Classification System (PD-PCS)
Comparison of change in pain between active stimulation and sham stimulation in Baseline, 15 days after the end of the 10th session (questionnaire will be applied by phone call at that time) and at follow-up (1 month and 3 months post-intervention), that will be measured through Parkinson Disease Pain Classification System, which scores and classifies parkinson disease-related pain into 3 groups (nociceptive, neuropathic or nociplastic), in relation to intensity, frequency and interference in activities of daily living. Higher scores indicate greater severity of pain
Measured: 4 months
Study of motor evoked potentials (MEPS)
Motor evoked potentials (MEPs) induced by transcranial magnetic stimulation (TMS) will be measured in active and sham stimulation, before the protocol starts and immediately after the 10th session.Thus, in the present study, we sought to evaluate the effects of rTSMS on the characteristics of MEPs at baseline and shortly after the end of the 10th session, evaluating whether rTSMS is a useful technique to facilitate downward impulse and promote motor function in PD.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel, phase III clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubens G Cury, MD PHD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938673
- Sponsor's protocol ID
- 57119022.4.1001.0068
- Status last verified
- May 2023
- First submitted
- 2 Jun 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arii Y, Sawada Y, Kawamura K, Miyake S, Taichi Y, Izumi Y, Kuroda Y, Inui T, Kaji R, Mitsui T. Immediate effect of spinal magnetic stimulation on camptocormia in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1221-6. doi: 10.1136/jnnp-2014-307651. Epub 2014 Apr 29.
PubMed 24780955Chung CL, Mak MK, Hallett M. Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease. Ann Neurol. 2020 Nov;88(5):933-945. doi: 10.1002/ana.25881. Epub 2020 Sep 8.
PubMed 32827221de Andrade EM, Ghilardi MG, Cury RG, Barbosa ER, Fuentes R, Teixeira MJ, Fonoff ET. Spinal cord stimulation for Parkinson's disease: a systematic review. Neurosurg Rev. 2016 Jan;39(1):27-35; discussion 35. doi: 10.1007/s10143-015-0651-1. Epub 2015 Jul 30.
PubMed 26219854Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.
PubMed 19299613Reis Menezes J, Bernhart Carra R, Aline Nunes G, da Silva Simoes J, Jacobsen Teixeira M, Paiva Duarte K, Ciampi de Andrade D, Barbosa ER, Antonio Marcolin M, Cury RG. Transcutaneous magnetic spinal cord stimulation for freezing of gait in Parkinson's disease. J Clin Neurosci. 2020 Nov;81:306-309. doi: 10.1016/j.jocn.2020.10.001. Epub 2020 Oct 20.
PubMed 33222935Takakusaki K. Neurophysiology of gait: from the spinal cord to the frontal lobe. Mov Disord. 2013 Sep 15;28(11):1483-91. doi: 10.1002/mds.25669.
PubMed 24132836Yadav AP, Nicolelis MAL. Electrical stimulation of the dorsal columns of the spinal cord for Parkinson's disease. Mov Disord. 2017 Jun;32(6):820-832. doi: 10.1002/mds.27033. Epub 2017 May 12.
PubMed 28497877Yang YR, Tseng CY, Chiou SY, Liao KK, Cheng SJ, Lai KL, Wang RY. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair. 2013 Jan;27(1):79-86. doi: 10.1177/1545968312451915. Epub 2012 Jul 10.
PubMed 22785003Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
PubMed 22850494Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
PubMed 21865071Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.
PubMed 25447740Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
PubMed 27862267Samotus O, Parrent A, Jog M. Spinal Cord Stimulation Therapy for Gait Dysfunction in Advanced Parkinson's Disease Patients. Mov Disord. 2018 May;33(5):783-792. doi: 10.1002/mds.27299. Epub 2018 Feb 14.
PubMed 29442369de Lima-Pardini AC, Coelho DB, Souza CP, Souza CO, Ghilardi MGDS, Garcia T, Voos M, Milosevic M, Hamani C, Teixeira LA, Fonoff ET. Effects of spinal cord stimulation on postural control in Parkinson's disease patients with freezing of gait. Elife. 2018 Aug 2;7:e37727. doi: 10.7554/eLife.37727.
PubMed 30070204Mitsui T, Arii Y, Taniguchi K, Tsutsumi S, Takahara M, Mabuchi M, Sumitomo N, Matsuura M, Kuroda Y. Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial. Neurotherapeutics. 2022 Jul;19(4):1273-1282. doi: 10.1007/s13311-022-01213-y. Epub 2022 Jun 27.
PubMed 35759108
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Trans Spinal Magnetic Stimulation Associated With Treadmill Gait Training on Gait Disorders in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05938673
- Acronym / sponsor ID
- 57119022.4.1001.0068
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Non-invasive brain stimulation, Parkinson's disease, Spinal cord stimulation, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gait changes appear and become the main cause of disability, loss of independence, falls, fractures and reduced quality of life for patients with Parkinson Disease. Optimal gait management is complex and challenging. Some characteristics, such as gait variability, postural instability, and postural changes, continue to worsen over time despite optimal dopaminergic treatment, suggesting that additional interventions are needed. Given the physiology of gait and postural control in humans, spinal cord stimulation is a potential target for neuromodulatory approaches to gait and postural disorders. Repetitive transspinal magnetic stimulation ( rTSMS) has attracted a lot of attention, due to the possibility of modulating motor and sensory networks in a non-invasive way, activating directly the dorsal ascending pathways and projecting to the thalamic nuclei, cerebral cortex, and brainstem nuclei, thus stimulating descending motor tracts and interrupting aberrant oscillatory activity in corticobasal nuclei circuits.
The combination of non-invasive neuromodulation with other therapies can enhance the effectiveness of rehabilitation, increasing plasticity and clinical efficacy, offering a greater and more sustained effect than either therapy alone.It's recommended that patients with PD perform a specific exercise for walking, such as treadmill training (tt), that imposes an external rhythm and concentration of attention on gait, acting as an external cue or marker, promoting a more stable gait, reducing gait variability and decreasing risk of falls.
It is proposed, in this study, to develop a new treatment model through the integration of two promising and complementary approaches to improve gait disorders in PD: rTSMS and tt.
Thus, the investigators idealized the realization of the first randomized, double-blind, placebo-controlled, parallel, phase III clinical trial that will evaluate the efficacy of tt associated with rTSMS in patients with PD.
Detailed description
The primary objective is to evaluate the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on the change in rapid gait speed in Parkinson Disease patients. The investigators hypothesize that the association of repetitive transspinal magnetic stimulation with treadmill gait training should be superior to treadmill gait training alone in improving gait symptoms in patients with PD. Additionally, will be investigated the effects of treadmill gait training associated with repetitive transspinal magnetic stimulation on comfortable gait speed; in clinical and neurophysiological measures; in motor symptoms; in activities of daily living; in the ability to walk (total distance covered); in balance performance; in time to complete the turn; in the severity of the freezing of the gait; in mobility; in the level of physical activity; in the number and fear of falls and in the perception of quality of life of patients with PD. In addition, the possible side effects of the intervention will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel, phase III clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Sham repetitive transpinal magnetic stimulation | Sham comparator | Other: Sham stimulationIn the Sham group a coil will be positioned in the T2-T3 thoracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. |
| Active repetitive transpinal magnetic stimulation | Active comparator | Other: Active stimulation- intermittent theta-burst (iTBS) stimulationIn the Active group, the patient will receive intermittent theta burst stimulation (iTBS) in the T2-T3 region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over the age of 18;
- Participants with PD at Hoehn Yahr stages between 2 and 4 (moderate disease) while on-medication (i.e., at the time when their usual dopaminergic medication is clinically effective), whose primary symptom includes gait disturbance (score equal to or greater than 1 in subitem 2.12 of the MSD-UPDRS scale). Patients will be evaluated for the presence of freezing gait (freezing) through the Freezing of Gait Score (FOG-SCORE).
- While on on-medication, be able to walk independently for 30 meters or with a unilateral assistive device.
- Mini Mental State Examination (MMSE) score greater than or equal to 23.
- Sign the informed consent form.
Key exclusion criteria (11 listed)
- Patients with unstabilized psychiatric comorbidities;
- Individuals who have other neurological disorders, musculoskeletal, orthopedic, cardiovascular and respiratory disorders that may affect the ability to walk on the treadmill will be excluded.
- Individuals with labyrinthine problems, using medication that may interfere with balance and performance in tests and treadmill training will be excluded.
- Individuals who have undergone deep brain stimulation surgery or epidural spinal cord stimulation will be excluded.
- Patients with uncontrolled infection or other uncontrolled pre-existing medical conditions (eg uncontrolled diabetes, high blood pressure, symptomatic lung or heart disease);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active stimulation- intermittent theta-burst (iTBS) stimulationDuring active stimulation, patients will receive intermittent theta-burst (iTBS) stimulation in T2-T3 toracic region while seated using a circular magnetic coil positioned at 90º, handle facing to the right, connected to a magnetic stimulator.Each participant will receive a total of 1,200 rTsMS pulses at 120% of resting motor threshold, determined by abdominal muscle contractions. In 3 minutes and 58 seconds, 20 trains with 20 bursts and each burst with 3 pulses at 50 Hz repeated at 5Hz with an intertrain interval of 8 seconds will be applied.Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity. | Other | Active repetitive transpinal magnetic stimulation |
| Sham stimulationDuring sham stimulation, a circular magnetic coil will be positioned in the T2-T3 toracic region disconnected to the stimulation device and the active coil will be positioned about 15 cm behind the patient, away from his field of vision, to provide sound stimulus. To create a sensation of muscle contraction and impression of active stimulation, the group will be submitted to the sensory effect of transcutaneous electrical neurostimulation (TENS) for 5 minutes, with surface electrodes placed in parallel at the T2-T3, with the parameters (80Hz,150ms, 60 mA).Immediately after, participants will proceed with 30 minutes of treadmill training, starting at 80% of the comfortable walking speed. Progressive speed increments of 0.2 km/h will be performed every 5 minutes as tolerated. The intensity of the exercise will be adjusted to the patient's tolerance and maintained between light to moderate intensity. | Other | Sham repetitive transpinal magnetic stimulation |
Primary outcome
10 meter walk test- Fast walking speed
Time frame: 4 months
Comparison of the change in fast gait speed between active stimulation and sham stimulation during Baseline, right after the end of the 10th session and follow-up (1 month and 3 months post-intervention). Longer time to complete the test results in slower gait speed and worse performance
16 secondary outcomes
10 meter walk test- Confortable walking speed
Time frame: 4 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part II and III
Time frame: 4 months
Freezing of Gait Score- (FOG- SCORE)
Time frame: 4 months
2 Minute Walk Test
Time frame: 4 months
Timed up and Go (TUG)
Time frame: 4 months
Timed up and Go Dual Task (TUG-DT)
Time frame: 4 months
Timed 360° turn test
Time frame: 4 months
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: 4 months
Freezing of Gait Questionnaire (FOG-Q)
Time frame: 4 months
Falls and near falls
Time frame: 4 months
Human Activity profile (HAP)
Time frame: 4 months
Falls Efficacy Scale- International (FES-I)
Time frame: 4 months
Parkinson's Disease Questionnaire -39 (PDQ-39)
Time frame: 4 months
Non-Motor Symptoms Scale (NMSS)
Time frame: 4 months
The Parkinson Disease Pain Classification System (PD-PCS)
Time frame: 4 months
Study of motor evoked potentials (MEPS)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 24780955Arii Y, Sawada Y, Kawamura K, Miyake S, Taichi Y, Izumi Y, Kuroda Y, Inui T, Kaji R, Mitsui T. Immediate effect of spinal magnetic stimulation on camptocormia in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1221-6. doi: 10.1136/jnnp-2014-307651. Epub 2014 Apr 29.
- Background: PubMed 32827221Chung CL, Mak MK, Hallett M. Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease. Ann Neurol. 2020 Nov;88(5):933-945. doi: 10.1002/ana.25881. Epub 2020 Sep 8.
- Background: PubMed 26219854de Andrade EM, Ghilardi MG, Cury RG, Barbosa ER, Fuentes R, Teixeira MJ, Fonoff ET. Spinal cord stimulation for Parkinson's disease: a systematic review. Neurosurg Rev. 2016 Jan;39(1):27-35; discussion 35. doi: 10.1007/s10143-015-0651-1. Epub 2015 Jul 30.
- Background: PubMed 19299613Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.
- Background: PubMed 33222935Reis Menezes J, Bernhart Carra R, Aline Nunes G, da Silva Simoes J, Jacobsen Teixeira M, Paiva Duarte K, Ciampi de Andrade D, Barbosa ER, Antonio Marcolin M, Cury RG. Transcutaneous magnetic spinal cord stimulation for freezing of gait in Parkinson's disease. J Clin Neurosci. 2020 Nov;81:306-309. doi: 10.1016/j.jocn.2020.10.001. Epub 2020 Oct 20.
- Background: PubMed 24132836Takakusaki K. Neurophysiology of gait: from the spinal cord to the frontal lobe. Mov Disord. 2013 Sep 15;28(11):1483-91. doi: 10.1002/mds.25669.
- Background: PubMed 28497877Yadav AP, Nicolelis MAL. Electrical stimulation of the dorsal columns of the spinal cord for Parkinson's disease. Mov Disord. 2017 Jun;32(6):820-832. doi: 10.1002/mds.27033. Epub 2017 May 12.
- Background: PubMed 22785003Yang YR, Tseng CY, Chiou SY, Liao KK, Cheng SJ, Lai KL, Wang RY. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair. 2013 Jan;27(1):79-86. doi: 10.1177/1545968312451915. Epub 2012 Jul 10.
- Background: PubMed 22850494Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
- Background: PubMed 21865071Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
- Background: PubMed 25447740Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.
- Background: PubMed 27862267Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens G Cury, MD PHD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active stimulation- intermittent theta-burst (iTBS) stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test- Fast walking speed (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05938673, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.